BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 3253640 · Received July 17, 2013

    Report

    Report Number
    2020362-2013-00326
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 3, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE. THE ALARM DID NOT POWER ON WHEN USING NEW BATTERIES, AN EXTERNAL POWER SUPPLY OR A 9V ADAPTER. HOWEVER, THERE IS BATTERY LEAKAGE RESIDUE INSIDE THE BATTERY COMPARTMENT AND ON THE BATTERY CONTACTS AND SPRINGS. THE BATTERY DOOR IS MISSING AND THE AQUALERT WATER INDICATOR LABEL SHOWS EXPOSURE TO MOISTURE. WARNING LABEL IS MISSING AND THERE IS RESIDUE WHERE IT SHOULD BE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHEN THE ALARM IS IN USE AND THE HOLD/SUSPEND BUTTON IS PUSHED THE ALARM CONTINUOUSLY SOUNDS. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331948 KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OVER-THE-MATTRESS SENSOR PAD, MODEL 8374, LOT UNK